Metabolic Dysfunctions Associated with Pharmacological Treatment of Schizophrenia - TREATMENT-patients

Fundación para la Investigación e Innovación Biosanitaria de Asturias (FINBA)0 个研究点目标入组 48 人开始时间: 2018年3月2日最近更新: 2018年6月18日

适应症

试验速览

暂无简介。

•1.Informed consent signature
•2.Age =18 years and <65 years.
•3.First psychotic episode; the diagnosis of a current psychotic episode must be confirmed by the International Neuropsychiatric Interview (MINI) and correspond to one of these diagnoses of the group of schizophrenia and other psychotic disorders according to the international classification of diseases DSM-IV TR:
•a.Schizophrenia (295.30, 295.10, 295.20, 295.90, 295.60)
•b.Schizophreniform disorder (295.40)
•c.Delusional disorder (297.1)
•d.Brief Psychotic disorder (298.8)
•e.Unespecified Psychosis (298.9)
•f.Schizoaffective disorder (295.7)
•g.Bipolar I disorder with psychotic features (296.02, 296.42, 296.55)
•h.Major depressive disorder with psychotic features (296.23)
•4.Not having taken any type of psychotropic drug in the period of one month prior to the first blood draw, with the exception of benzodiazepines.
•5.Not having previously taken antipsychotic treatment.
•6.Ability to understand and carry out correctly the development of the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 48
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Contraindications for treatment with olanzapine or aripiprazole
•2.Electroconvulsive therapy in the current episode.
•3.Psychopharmacological treatments (other than benzodiazepines) in the month prior to the inclusion of the study
•4.During the study, the patient may only be in pharmacological treatment with one of the two antipsychotics under study (Olanzapine or Aripiprazole) and may only receive psychopharmacological treatment concomitant with the following benzodiazepines: dipotasic chloracepate and lormetazepam.
•5.Subjects with a BMI outside the range 18.5-30.0.
•6.Dependence or abuse of drugs (cannabis, opiates, cocaine or amphetamines) according to DSM-IVTR criteria. Patients may be included in which the use of drugs is sporadic and not usual
•7.Alcohol consumption in the last month within the levels of risk to health (consumption = 35 U / week in men and = 21 U / week in women).
•8.Women who are pregnant or breast-feeding.
•9.Participation in another pharmacological research study in the previous 3 months.
•10.Inability to understand information about the study.

发起方

Fundación para la Investigación e Innovación Biosanitaria de Asturias (FINBA)